FDA.reportPublic FDA data

Application 020834

Type
NDA
Sponsor
JOHNSON AND JOHNSON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROGAINE EXTRA STRENGTH (FOR MEN)MINOXIDILSOLUTION;TOPICAL5%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICALRLD, RS1997-11-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020834-001ROGAINE EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICALRLD, RS1997-11-14e64feba35796…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mens Rogaine Extra Strength UnscentedMINOXIDILKenvue Brands LLCccaecec5-5348-4b24-9190-5464c50f6d802024-09-06WarningsExact identifier
application applno (NDA): 020834
application number: NDA020834
ndc (product): 69968-0089

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-4805Qilib Hair Regrowth Treatment for MenMINOXIDILGalderma Laboratories, L.P.NDACurrent
0299-4820Qilib Hair Regrowth Treatment for WomenMINOXIDILGalderma Laboratories, L.P.NDACurrent
63981-111Mens KirklandMinoxidilCostco Wholesale CorporationNDACurrent
69968-0089Mens Rogaine Extra Strength UnscentedMinoxidilJohnson & Johnson Consumer Inc.NDACurrent
69968-0089Mens Rogaine Extra Strength UnscentedMinoxidilJohnson & Johnson Consumer Inc.NDACurrent
69968-0089Mens Rogaine Extra Strength UnscentedMinoxidilJohnson & Johnson Consumer Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84765SUPPL 2026-01-15
84761SUPPL 2026-01-15
13555SUPPL2015-04-29
3503SUPPL2015-04-29
25995SUPPL2006-09-20
3502SUPPL2005-06-07
25994SUPPL2004-06-30
20993ORIG2003-08-08
35468SUPPL2003-05-29
3501SUPPL2003-02-14